Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Type 2 Diabetes
Type 2 Diabetes

About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, Diabetes Medicines: Oral Hypoglycemic Drugs and Insulins., Umbilical Cord/placenta-Derived MSC, Transplantation
Eligibility Criteria
Inclusion Criteria:
- Free will taking part in the study and ability to provide written informed consent
- Type 2 diabetes mellitus (as guideline WHO, 1999)
- Age 18-80 years old, Male/Female
- 19≤Body mass index (BMI)≤30㎏/㎡
- Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7%
- Intravenous insulin tolerance test(ITT)indicate patient being insulin resistance
- Not pregnant or nursing
- No moderate or sever organ dysfunction: Ejection fraction>45%; Creatinine <176 mmol/L
- No active severe viral or fungus infection
Exclusion Criteria:
- Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction)
- Active infection requiring treatment
- Unexplained febrile illness
- Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection
- Psychiatric condition that would limit informed consent
- Patient has enrolled another clinical trial study within last 4 weeks.
Sites / Locations
- Department of Hematology of the 2nd Hospital of Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
MSC and the oral hypoglycemic drugs
MSC and insulins
MSC and the combination of drugs and insulins
1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former oral hypoglycemic drugs, such as Dimethylbiguanide, Glurenorm and Acarbose, et al. and regulates the dosage for 1 year.
1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former insulins and regulates the dosage for 1 year.
1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former combination of the oral hypoglycemic drugs and insulins and regulates the dosage for 1 year.